A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients with Non-radiographic Axial Spondyloarthritis (nr-axSpA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response
研究概览
简要总结
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
详细描述
The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo in patients with nr-axSpA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients at least 18 years of age at the time of screening.
- •Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
- •Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
- •Total back pain as measured by NRS ≥ 4 at baseline
排除标准
- •Patients with other uncontrolled active inflammatory diseases.
- •Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
- •Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •History of cancer.
- •Known or suspected history of immunosuppression.
- •Known with allergic or intolerant to mometasone furoate spray or 608/placebo.
研究组 & 干预措施
608 Dose A
608 Dose A subcutaneous (SC) injection.
干预措施: 608 (Drug)
608 Dose B
608 Dose B subcutaneous (SC) injection.
干预措施: 608 (Drug)
Placebo
Placebo subcutaneous (SC) injection.
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response
时间窗: From Baseline to Week 16
Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the NRS signifies higher severity.
次要结局
- The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response(From Baseline to the Week 16)
- 608 Concentration in Serum(From Baseline to Week 24)